OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5R (UDI 04953170328817)Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 04953170328817), received between Feb 24, 2019 and Aug 13, 2026 — classified as 9 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K221690); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Dec 4, 2023Class IIOpen, Classified

   Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.

   Z-0685-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50244058 ↗
• MalfunctionAug 13, 2026Failure to Clean Adequately

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240835 ↗
• MalfunctionAug 12, 2026Corroded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229710 ↗
• MalfunctionJun 15, 2026Break

  THE CUSTOMER RETURNED THE CYSTONEPHROFIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT BROKEN/CHIPPED GLUE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505567 ↗
• MalfunctionJun 9, 2026Failure to Clean Adequately

  THE CUSTOMER REPORTED SOMETHING STUCK IN THE PORT DURING REPROCESSING INVOLVING AN OLYMPUS CYSTONEPHROFIBERSCOPE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25451852 ↗
• MalfunctionJun 8, 2026Corroded

  THE CUSTOMER REPORTED RUST INSIDE INSTRUMENT CHANNEL AND VENTING CONNECTOR DURING REPROCESSING INVOLVING AN OLYMPUS CYSTONEPHROFIBERSCOPE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436417 ↗
• MalfunctionMay 22, 2026Residue After Decontamination

  THE FIBERSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF INTERNAL DISCOLORATION. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, IT WAS FOUND THAT THE PLASTIC DISTAL END CONTROL BODY CONTAINED A RESIDUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260070 ↗
• MalfunctionApr 15, 2026Loss of or Failure to Bond

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BENDING SECTION COVER ADHESIVE OF THE CYSTO-NEPHRO VIDEOSCOPE WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889777 ↗
• MalfunctionApr 13, 2026Environmental Particulates

  THE CYSTONEPHROFIBERSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A COMPLAINT OF LEAKING AND A BROKEN LENS. THIS DOES NOT INDICATE A REPORTABLE EVENT. HOWEVER, A REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, IT WAS OBSERVED THAT THE DEVICE HAD A DIRTY LENS (ENVIRONMENTAL PARTICULATES, LENSES). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24857385 ↗
• MalfunctionApr 3, 2026Corroded

  THE CYSTONEPHROFIBERSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF A FAILED LEAK TEST. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, A CORRODED ETHYLENE OXIDE (GAS) VALVE CONNECTOR WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781668 ↗
• MalfunctionMar 31, 2026Crack

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CYSTONEPHROFIBERSCOPE EXHIBITED A CHIP ON THE END OF THE PLASTIC END DISTAL COVER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742228 ↗
• MalfunctionMar 2, 2026Loss of or Failure to Bond; Crack; Scratched Material

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ADHESIVE OF THE FIBERSCOPE'S CURVED RUBBER WAS CHIPPED, LIFTED, AND SCRATCHED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491993 ↗
• MalfunctionFeb 25, 2026Material Deformation

  IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE CYSTO-NEPHRO FIBERSCOPE EXHIBITED THE A-RUBBER GLUE CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442243 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A CYSTOSCOPY PROCEDURE, A PATIENT REPORTED URINARY TRACT INFECTION (UTI) SYMPTOMS 3 DAYS AFTER THE PROCEDURE DATE WITH THE USE OF THIS CYSTONEPHROFIBROSCOPE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THE PATIENT EXHIBITED BURNING SENSATION WITH URINATION, URINARY FREQUENCY AND FEELING OF INCOMPLETE VOIDING. THE PATIENT WAS THEN TREATED WITH ANTIBIOTIC FOR 7 DAYS. THERE WERE NO CULTURE TESTS DONE WITH THE PATIENT AND THE CYSTONEPHROFIBROSCOPE. THE CUSTOMER NOTED IT WAS QUITE UNUSUAL TO HAVE UTIS IN THAT SPAN OF TIME. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THIS REPORT IS FOR PATIENT 4 OF 4.

  Patient problems: Dysuria; Urinary Frequency / Polyuria; Urinary Retention; Urinary Tract Infection

  MAUDE report 24406150 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A CYSTOSCOPY PROCEDURE, A PATIENT REPORTED URINARY TRACT INFECTION (UTI) SYMPTOMS 1 DAY AFTER THE PROCEDURE DATE WITH THE USE OF THIS CYSTONEPHROFIBROSCOPE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THE PATIENT EXHIBITED BURNING SENSATION WITH URINATION, ABDOMINAL PAIN, AND URINARY URGENCY. THE PATIENT WAS THEN TREATED WITH ANTIBIOTIC FOR 7 DAYS. THERE WERE NO CULTURE TESTS DONE WITH THE PATIENT AND THE CYSTONEPHROFIBROSCOPE. THE CUSTOMER NOTED IT WAS QUITE UNUSUAL TO HAVE UTIS IN THAT SPAN OF TIME. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THIS REPORT IS FOR PATIENT 3 OF 4.

  Patient problems: Abdominal Pain; Bladder Dysfunction; Dysuria; Urinary Tract Infection

  MAUDE report 24406010 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A CYSTOSCOPY PROCEDURE, A PATIENT REPORTED URINARY TRACT INFECTION (UTI) SYMPTOMS 2 DAYS AFTER THE PROCEDURE DATE WITH THE USE OF THIS CYSTONEPHROFIBROSCOPE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THE PATIENT EXHIBITED BURNING SENSATION WITH URINATION, URINARY FREQUENCY AND FEELING OF INCOMPLETE VOIDING. THE PATIENT WAS THEN TREATED WITH ANTIBIOTIC FOR 7 DAYS. THERE WERE NO CULTURE TESTS DONE WITH THE PATIENT AND THE CYSTONEPHROFIBROSCOPE. THE CUSTOMER NOTED IT WAS QUITE UNUSUAL TO HAVE UTIS IN THAT SPAN OF TIME. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THIS REPORT IS FOR PATIENT 1 OF 4.

  Patient problems: Dysuria; Urinary Frequency / Polyuria; Urinary Retention; Urinary Tract Infection

  MAUDE report 24405487 ↗
• MalfunctionFeb 4, 2026Material Separation

  IT WAS OBSERVED DURING THE DEVICE INVESTIGATION THAT THE CYSTO-NEPHRO FIBERSCOPE HAD A DETACHED GLUE AT THE DISTAL END OF THE BENDING SECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259393 ↗
• MalfunctionFeb 2, 2026Environmental Particulates

  IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE CYSTO NEPHRO FIBERSCOPE EXHIBITED A DIRTY OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240077 ↗
• MalfunctionJan 9, 2026Degraded; Material Discolored; Poor Quality Image; Residue After Decontamination; Optical Distortion

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CYSTONEPHROFIBERSCOPE HAD DIRT ON THE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24027034 ↗
• MalfunctionDec 16, 2025Material Integrity Problem; Material Integrity Problem

  NO ADDITIONAL INFORMATION REC FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824813 ↗
• MalfunctionDec 1, 2025Poor Quality Image; Poor Quality Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CYSTO-NEPHRO FIBERSCOPE EXHIBITED A DIRTY OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681028 ↗
• MalfunctionNov 19, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CYSTONEPHROFIBERSCOPE EXHIBITED RUST INSIDE THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23600950 ↗
• MalfunctionNov 4, 2025Corroded; Corroded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEXIBLE SCOPE EXHIBITED RUST AND A TEAR INSIDE THE CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466991 ↗
• MalfunctionNov 3, 2025Separation Failure; Separation Failure

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A BIOPSY PORT THAT FELL OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453009 ↗
• MalfunctionOct 29, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OBJECTIVE LENS OF THE CYSTONEPHROFIBERSCOPE WAS DIRTY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415731 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K221690. One submission often covers many models, so check the product and lot details in each record.

• Z-0684-2024 · Dec 4, 2023 · Open, Classified
  Model No. CYF-5, Cystonephrofiberscope
• Z-0331-2024 · Sep 25, 2023 · Open, Classified
  Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.